Associate Director, Analytical Development & QC

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.   We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.   Responsibilities: * Lead analytical development and support QC activities related to the development and commercialization of peptide drug substances.. * Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide drug substance. * Through our external network, lead the development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories. * Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization. * Author relevant CMC sections to enable global regulatory filings. * Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed. * Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making. * Collaborate with cross-functional line functions to ensure CMC and program goals are met. * Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight.     Required Qualifications: * A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.). * Or an advanced degree with 5+ years * Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy. Experience in the analytical support of drug substance PPQ/Process Validation. * Demonstrated analytical project leadership and cross-functional team participation. * Experience in setting commercial specifications. * Experience in authoring regulatory documents, including NDA experience * Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements. * Strong understanding of all applicable ICH guidelines. * Method validation experience. * Experience with oversight of the analytical activities at CDMOs and/or CTLs. * Sound problem-solving skills with technically driven decision-making ability. * Effective written and verbal communication and interpersonal skills. * Innovative team-player with high energy for our dynamic company environment.   Preferred Qualifications: * Knowledge and experience in analytical development of injectable products, and associated control strategies * Knowledge and experience in analytical development of small molecules and solid oral dosage forms. * Successful support of at least one NDA and commercial launch. * Synthetic peptide manufacturing knowledge. * Experience with statistics and applying statistics to analytical chemistry. * Regulatory Inspection experience.   Education: * A Bachelor’s degree with 10+ years or an advanced degree with 5+ years of relevant experience * Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.   Additional Information: * This position requires some travel to domestic and international destinations. * In rare occasions, this position may require working in environments where there may be specific gowning or dress code requirements. Salary Range $155,000—$190,000 USD For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:  Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances. E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.  #LI-Hybrid

About Inizio Ignite: Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Company Descriptor Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward. About the team: We have recently established a new Scripting Team in India, based in Gurgaon. This hub is part of the global Operations team and sits within the Data Management & Dashboard Delivery (DMD) capability. The team supports ad hoc, tracking and syndicated quantitative studies as the business transitions from an outsourced vendor model to a stronger blended / in-house delivery model. The team scripts and maintains online questionnaires for healthcare professionals, patients and other key stakeholders. By integrating complex logic, customized routing, validation checks and robust testing, the team ensures high-quality data capture and supports downstream data processing, analytics, dashboarding, reporting and insight generation. As the team scales, the priority is to strengthen scripting quality, technical governance, capability-building and readiness for more complex programming requirements. Your primary role: The Scripting Senior Manager - SME is a senior Subject Matter Expert role within the Scripting department, reporting to the Associate Director, Data Management & Dashboard Delivery (DMD). The role provides the highest level of in-house scripting expertise for India DMD and acts as the technical authority, escalation point and quality owner for complex survey programming. This role is critical to scaling the scripting function and de-risking the transition from outsourced delivery to a blended / in-house model. It combines hands-on complex scripting with technical governance, quality ownership, team coaching, process development, capability-building and stakeholder advisory. The successful candidate will help build confidence that the India team can deliver increasingly complex scripting requirements to the required quality standard while reducing dependency on external vendors. This will include: * Acting as the senior technical SME for the Scripting department, providing expert oversight across complex online survey programming, advanced logic, routing, validation, quotas and respondent experience. * Providing hands-on scripting and programming of high-complexity online surveys using the Confirmit platform, including custom logic, advanced routing, validations, quality controls and troubleshooting. * Exploring emerging survey technology, AI-enabled research tools and automation opportunities, with the ability to assess which solutions can practically improve scripting quality, speed and scalability. * Acting as the escalation point for complex scripting issues, technical risks and quality concerns across ad hoc, tracking, Pathfinder, Ignite, syndicated and other quantitative study types. * Providing upfront technical review of complex questionnaires to identify scripting risks, confirm feasibility and recommend efficient survey design solutions * Supporting the transition from an outsourced model to a blended / in-house model by assessing scripting complexity, identifying readiness gaps, highlighting capability or resourcing risks and capturing lessons learned as work moves in-house. * Building and delivering an upskilling plan for the scripting team, with particular focus on complex programming requirements such as conjoint exercises, segmentations, advanced routing, trackers and syndicated study complexity. * Providing technical guidance, mentoring and quality feedback to Scripting Senior Managers, Managers and Executives; line management may be included where required as the team scales. * Partnering closely with Research, Project Management, Data Processing, Dashboarding and Analytics teams to ensure scripting design supports accurate downstream data flow, tabulation, dashboarding and reporting. * Advising internal stakeholders on scripting best practice, feasibility, risks, options and solutions, translating technical considerations clearly for non-technical audiences. Your skills and experience: * More than 11 years of experience in a senior scripting role within a market research agency, with evidence of operating at SME / technical lead level; healthcare / life sciences market research experience is strongly preferred. * Deep proficiency in Confirmit's scripting platform, including authoring, complex logic implementation, deployment, testing, troubleshooting and quality control. * Strong practical knowledge of JavaScript, HTML and CSS for customizing survey functionality, layout and respondent experience. * Experience using AI or automation tools to improve survey scripting, QC, documentation, code review or workflow efficiency. * Proven experience scripting complex quantitative research studies, ideally including trackers, syndicated studies, conjoint exercises, segmentations, complex routing, quotas and validation requirements. * Strong understanding of quantitative research methodologies, questionnaire structures, healthcare market research standards and the downstream implications of scripting decisions for data processing, analytics, dashboarding and reporting. * Experience establishing, maturing or improving an in-house scripting function, ideally including process design, quality frameworks, documentation, training plans and transition from outsourced delivery. * Demonstrable experience mentoring, coaching and developing scripting team members, including quality feedback, capability-building and support for complex technical problem solving. * Strong analytical judgement, problem-solving ability and the confidence to identify, escalate and resolve quality, feasibility or delivery risks. * Excellent communication skills, with the ability to explain technical issues, options and implications to non-technical stakeholders in an international environment. Ideal profile: * You are a hands-on technical expert who can operate as the senior SME, quality owner, escalation point, coach and trusted advisor to senior stakeholders. * You are comfortable sitting above the standard Senior Manager role, providing expert challenge, guidance and technical assurance without losing the ability to get hands-on when needed. * You are proactive, dedicated and enthusiastic, with a can-do attitude and a strong ownership mindset. * You demonstrate a high level of accuracy and attention to detail, as well as strong organisation and prioritization skills. * You are comfortable working in a scaling team where processes are still being built and where ambiguity needs to be turned into clear ways of working. * You are collaborative and able to build effective relationships across Research, Project Management, DMD, Data Processing, Dashboarding, Analytics and UK stakeholder groups. * You communicate ideas, risks and issues in a clear, practical and solution-focused way. * You are motivated by the opportunity to build a new scripting capability, strengthen in-house delivery and develop others. * Experience developing reusable scripting templates, code libraries, macros, checklists, QC frameworks or automation tools that reduce manual effort and improve the TAT Life at Research Partnership: We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide: - A comprehensive training and development programme for all staff, from entry level apprentice to senior management. - Opportunities for international travel and collaboration. - A relaxed and friendly working environment.   Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.